Status:
RECRUITING
Awareness Detection and Communication in Disorders of Consciousness
Lead Sponsor:
University of Ulster
Collaborating Sponsors:
National Rehabilitation Hospital, Dublin, Ireland (NRH)
Belfast Health and Social Care Trust
Conditions:
Disorder of Consciousness
Paralysis
Eligibility:
All Genders
10-80 years
Phase:
NA
Brief Summary
STUDY OVERVIEW Brain injury can result in a loss of consciousness or awareness, to varying degrees. Some injuries are mild and cause relatively minor changes in consciousness. However, in severe cases...
Detailed Description
PRINCIPLE RESEARCH QUESTIONS The project will address a number key principal research questions largely based on two phases to the study. Phase/study 1 1. What percentage of disorder of consciousnes...
Eligibility Criteria
Inclusion
- Study 1 - Initial assessment/screening
- Disorder of consciousness or low awareness state diagnosis ranging from unclear diagnosis in low awareness states, vegetative state and minimally conscious diagnosis. Those with locked in syndrome / completed locked in syndrome resulting from injury or disease e.g., motor neuron disease who do not have health problems that would preclude them from participating may be assessed but considered as a separate cohort to those with low awareness states.
- acute, post-acute patients where appropriate
Exclusion
- Participants with brain related diseases or illnesses (e.g., progressive neurological condition or uncontrolled epilepsy) or suffer from pain (these may adversely affect the brain data produced) and are deemed to be unsuitable for the trials by clinical teams.
- Current consumption of medications that cause excessive fatigue or adversely affect cognitive functioning
- Where English is not the individual's first language
- Participant with excessive uncontrollable arm or head movement or teeth grinding as EEG signal quality will be degraded significantly.
- Study 2 - BCI training
- Inclusion Criteria:
- \- Those identified in study 1 to have a level of awareness based on observed appropriate brain activations and/or those who have known awareness but are target groups for movement independent assistive devices and technologies controlled using a brain-computer interface.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03827187
Start Date
February 8 2022
End Date
August 1 2026
Last Update
December 13 2024
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
National Rehabilitation Hospital of Ireland
Dublin, Ireland, A96 E2H2
2
Castel Froma Neuro Care
Warwick, Warwickshire, United Kingdom, CV32 6LL
3
Northern Health and Social Care Trust
Antrim, United Kingdom, BT41 2RL
4
Barnsley Hospital NHS Foundation Trust
Barnsley, United Kingdom, S75 2EP